Sr Quality Engineer-New Product Introduction

Medtronic•Juncos, PR

About The Position

The Senior Quality Engineer provides quality leadership and oversight for new product introduction activities, ensuring products and manufacturing processes meet regulatory, quality, and business requirements. This role partners with cross-functional teams to drive risk management, design and process validation, change control, and product transfer activities from development through commercial launch, while supporting continuous improvement and risk burndown initiatives at the site. This role also provides oversight to equipment and process validation activities at the site. The Senior Quality Engineer is responsible for supporting product and process quality within a regulated manufacturing environment. This role collaborates across functions to establish quality standards, lead quality improvement initiatives, analyze quality data, and ensure compliance with applicable regulations and quality system requirements while driving continuous improvement and operational excellence.

Requirements

Bachelor's Degree in Engineering and a minimum of 4 years of relevant experience; OR Master's Degree and a minimum of 2 years of relevant experience; OR PhD.
Experience supporting quality engineering activities within a regulated manufacturing or medical device environment.
Experience applying quality tools and methodologies to support investigations, corrective actions, and process improvements.
Experience collaborating with cross-functional teams including engineering, manufacturing, and quality organizations.

Nice To Haves

Experience with Design Controls, Risk Management, and quality engineering activities throughout the product lifecycle.
Experience leading cross-functional projects and influencing stakeholders in a matrixed environment.
Expertise with statistical analysis tools including Minitab, Statistical Process Control (SPC), and trend analysis.
Lean Six Sigma Green Belt or Black Belt certification.
Experience with validation lifecycle management, change control, quality risk management, reliability engineering, product performance testing, and mentoring engineers or project teams.

Responsibilities

Lead and support continuous improvement projects and quality initiatives that enhance product quality, process performance, and compliance.
Develop, implement, maintain, and improve quality standards and protocols for materials, components, and finished products.
Partner with engineering and manufacturing teams to ensure quality requirements are effectively integrated into manufacturing processes and operations.
Design and implement inspection, testing, and evaluation methods to verify product quality, equipment performance, and process effectiveness.
Conduct statistical analysis and quality assurance activities to evaluate product and process performance, identify trends, and support data-driven decision making.
Investigate nonconforming products or materials, determine root causes, and ensure appropriate corrective actions are implemented and documented.
Ensure quality documentation, corrective actions, and quality system activities comply with applicable regulatory and internal requirements.
Provide technical quality support across design, incoming materials, production control, product evaluation, reliability, inventory control, research and development, or other quality-related areas as needed.